Cleared Traditional

K094005 - FORA G31A/TD-4256A BLOOD GLUCOSE MONITO...

K094005 is the FDA 510(k) clearance for FORA G31A/TD-4256A BLOOD GLUCOSE MONITO... by Taidoc Technology Corporation. It is a Class 2 Chemistry device (product code NBW) cleared through the Traditional 510(k) pathway after a 128-day FDA review.

K094005 · Taidoc Technology Corporation · Chemistry device
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May 2010
Decision
128d
Days
Class 2
Risk

K094005 is an FDA 510(k) clearance for the FORA G31A/TD-4256A BLOOD GLUCOSE MONITORING SYSTEM AND FORA G31B/TD-4256B BL.... Classified as System, Test, Blood Glucose, Over The Counter (product code NBW), Class II - Special Controls.

Submitted by Taidoc Technology Corporation (New Taipei City, TW). The FDA issued a Cleared decision on May 5, 2010 after a review of 128 days - within the typical 510(k) review window.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1345 - the FDA in vitro diagnostics and chemistry framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Taidoc Technology Corporation devices

Submission Details

510(k) Number K094005 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 28, 2009
Decision Date May 05, 2010
Days to Decision 128 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
40d slower than avg
Panel avg: 88d · This submission: 128d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code NBW System, Test, Blood Glucose, Over The Counter
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1345
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Chemistry devices follow this clearance model.

Regulatory Peers - NBW System, Test, Blood Glucose, Over The Counter

All 190
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